Milenia QuickLine HIT

Nom de l'organisation

Milenia Biotec GmbH

SRN

DE-MF-000028733

Statut du fabricant

Actif

7 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  Do not interchange components of packages of different batch codes.
• CW132

  Material Safety Data Sheets are available on request (see also www.milenia-biotec.com).
• CW999

  All samples, used Test Units, pipettes, tips, and other contaminated material should be handled carefully and as potentially infectious.
• CW267

  Contains biological material of animal origin
• CW007

  Do not use if package is damaged and consult instructions for use
• CW010

  Consult instructions for use or consult electronic instructions for use
• CW266

  The reagents provided in these kits contain materials of human and/or animal origin. Whenever human blood product is required for the preparation of these reagents, approved methods are used to test the blood for the antibodies to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of reagents of these types must exercise extreme care in full compliance with safety precautions in the manipulation of these biological materials as if they were infectious.

Marché principal en Allemagne ; disponible dans 1 pays au total.

Dénomination commerciale

Milenia QuickLine HIT

Code d'UDI-DI

04260177041206

Basic UDI-DI

B-04260177041206

Numéro de référence/catalogue

01059

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The STic Expert HIT is an in-vitro diagnostic lateral flow assay (kit) for the qualitative detection of human IgG antibodies against PF-4/polyanion complexes in citrated plasma or serum. The test is used to rule out HIT II (heparin-induced thrombocytopenia, type II) with a high degree of certainty in adult patients who have previously been treated with heparin and have an abnormal 4T score. The analysis is carried out exclusively by laboratory personnel indoors and was not developed for near-patient or self-use. The STic Expert HIT is evaluated manually (directly by the user using an evaluation card).

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0103020402PLATELET FACTOR 4

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• Date d'expiration
• Date de fabrication
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